Hämeenlinna Metabolic Syndrome Research Program: Surrogate Indicators for Atherosclerosis

NCT ID: NCT01119404

Last Updated: 2010-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-06-30

Study Completion Date

2014-12-31

Brief Summary

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Mechanisms that link metabolic syndrome to atherosclerosis are incompletely understood. As a part of Hämeenlinna Metabolic Syndrome Research Program (HMS) surrogate indicators for atherosclerosis are studied in 120 men with metabolic syndrome, 120 men with coronary heart disease and 80 physically active controls and in different settings.

Detailed Description

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Accumulation of oxidized low-density lipoproteins (LDL) in the intimae of arteries together with risk factors known to enhance atherosclerosis, damage the endothelium of the arterial wall. Dysfunction of the endothelium leads into loss of elasticity of the artery. Surrogate indicators of atherosclerosis might be seen already in the early phase of otherwise subclinical arterial disease.

In this study, we investigate calculated risk of the subjects (SCORE, FINRISK, Framingham score), platelet function and surrogate indicators for atherosclerosis like erectile dysfunction, plasma levels of oxidized LDL, arterial elasticity and biochemical markers for endothelial damage and dysfunction in different settings (case-only and case-control).

Conditions

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Metabolic Syndrome Coronary Heart Disease

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Metabolic Syndrome

120 men with metabolic syndrome

No interventions assigned to this group

Coronary Heart Disease (CHD)

120 men with angiographically verified CHD

No interventions assigned to this group

Control

80 physically active men

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Group 1: Metabolic syndrome

* 120 Finnish men with metabolic syndrome (MetS) defined according to National Cholesterol Education Program (NCEP) Adult Treatment Panel III
* MetS diagnosed in routine health examination and laboratory tests
* Age: 30 to 65 years

Group 2: Coronary heart disease (CHD)

* 120 Finnish men with angiographically proven CHD
* Age: 30 to 65 years

Group 3: Control

* 80 Finnish men
* Exercising physically more than three times a week and more than 30 minutes per exercise on regular basis
* Never been studied or treated because of cardiovascular disease
* Age: 30 to 65 years
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Linnan Klinikka Oy

OTHER

Sponsor Role collaborator

Mehiläinen Hämeenlinna, Finland

UNKNOWN

Sponsor Role collaborator

Finnish Red Cross Blood Service

OTHER

Sponsor Role collaborator

Kanta-Häme Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Central Hospital of Kanta-Häme

Principal Investigators

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Ari K Palomäki, MD PhD

Role: STUDY_DIRECTOR

Central Hospital of Kanta-Häme

Kalevi Oksanen, MD PhD

Role: STUDY_DIRECTOR

Central Hospital of Kanta-Häme

Locations

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Linnan Klinikka

Hämeenlinna, , Finland

Site Status COMPLETED

Mehiläinen Hämeenlinna

Hämeenlinna, , Finland

Site Status COMPLETED

Central Hospital of Kanta-Häme

Hämeenlinna, , Finland

Site Status RECRUITING

Finnish Red Cross Blood Transfusion Service

Helsinki, , Finland

Site Status COMPLETED

Countries

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Finland

Central Contacts

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Ari K Palomäki, MD PhD

Role: CONTACT

+35836294540

Kalevi Oksanen, MD PhD

Role: CONTACT

+35836292369

Facility Contacts

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Ari K Palomäki, MD PhD

Role: primary

+35836294540

Kalevi Oksanen, MD PhD

Role: backup

+35836292369

References

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Saarinen HJ, Lahtela J, Mahonen P, Palomaki A; Hameenlinna Metabolic Syndrome Research Program Study Group. The association between inflammation, arterial stiffness, oxidized LDL and cardiovascular disease in Finnish men with metabolic syndrome - a 15-year follow-up study. BMC Cardiovasc Disord. 2024 Mar 15;24(1):162. doi: 10.1186/s12872-024-03818-x.

Reference Type DERIVED
PMID: 38491429 (View on PubMed)

Pohjantahti-Maaroos H, Palomaki A, Kankkunen P, Husgafvel S, Knuth T, Vesterinen K, Oksanen K. Arterial elasticity and oxidized LDL among men with metabolic syndrome and different 10-year cardiovascular risk estimated by FINRISK and SCORE models. Ann Med. 2012 Aug;44(5):503-12. doi: 10.3109/07853890.2011.590520. Epub 2011 Jul 4.

Reference Type DERIVED
PMID: 21726125 (View on PubMed)

Pohjantahti-Maaroos H, Palomaki A, Hartikainen J. Erectile dysfunction, physical activity and metabolic syndrome: differences in markers of atherosclerosis. BMC Cardiovasc Disord. 2011 Jun 27;11:36. doi: 10.1186/1471-2261-11-36.

Reference Type DERIVED
PMID: 21707993 (View on PubMed)

Other Identifiers

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HMS-02

Identifier Type: OTHER

Identifier Source: secondary_id

KHMetS-02-AP

Identifier Type: -

Identifier Source: org_study_id

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